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The KMI Katalyst Radial Head Implant is generally indicated for radial head replacement arthroplasty. Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone stock inadequate.

The KMI Katalyst Radial Head implant is intended for use in radial head replacement arthroplasty. The system consists of modular stem and head components to accommodate variations in human anatomy. The design incorporates an adjustable stem length capability to allow stem length adjustment in-sito.
Materials: -Cobalt Chrome, per ASTM F75 -Stainless Steel BioDur 108 Alloy per ASTM F2229 -UHMWPE per ASTM 648-00
Function: The system functions as a replacement for the proximal radial head.

The provided text is related to a 510(k) premarket notification for a medical device called the "Katalyst Radial Head Implant." It describes the device, its intended use, and its substantial equivalence to other legally marketed devices.

However, the document does not contain any information about acceptance criteria, study design, device performance metrics, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone AI performance).

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study-related details. The document is a regulatory submission for premarket clearance based on substantial equivalence, not a report of a clinical performance study.

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